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A Long Term Study of Lanthanum Carbonate in Patients Requiring Dialysis Who Have Ived Lanthanum Carbonate in Previous Studies Defined by the Protocol.

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ClinicalTrials.gov Identifier: NCT00150540
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : September 17, 2007
Sponsor:
Information provided by:
Shire

Brief Summary:
The purpose of this study is to assess the safety of lanthanum carbonate in patients undergoing dialysis who have received lanthanum carbonate in the previous studies and wish to continue treatment.

Condition or disease Intervention/treatment Phase
Kidney Failure, Chronic Drug: Lanthanum carbonate Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 93 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long Term, Open Label Extension Study of Protocols LAM-IV-301, LAM-IV 303, LAM-IV 307 AND LAM-IV 308.
Study Start Date : October 2002
Actual Study Completion Date : January 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Treatment emergent adverse events following up to 24 months of treatment

Secondary Outcome Measures :
  1. Changes in pre-dialysis serum phosphate levels
  2. Control of pre-dialysis serum phosphate levels
  3. Plasma lanthanum levels


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who participated in LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 and received lanthanum carbonate
  • Patients must continue to require treatment with a phosphate binder for hyperphosphatemia
  • male or non-pregnant female who agrees to use an effective contraceptive method while on study treatment and for 30 days thereafter

Exclusion Criteria:

  • Patients withdrawn from LAM-IV-301, LAM-IV-303 OR LAM-IV-307 prior to randomization
  • Patients withdrawn from LAM-IV-301, LAM-IV-303, LAM-IV-307 OR LAM-IV-308 due to adverse events termed "possible" or "related" to study medication
  • Pregnant or lactating women

ClinicalTrials.gov Identifier: NCT00150540     History of Changes
Other Study ID Numbers: SPD405-309
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: September 17, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic